August 16 2016 51716 Minutes Review and vote 2 Reaching across Arizona to provide comprehensive quality health care for those in need PampT Meeting Date Changes 2016 Next Meeting Date ID: 702107
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AHCCCS Pharmacy and Therapeutics Committee
August 16, 2016Slide2
5-17-16 MinutesReview and vote
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quality health care for those in needSlide3
P&T Meeting Date Changes2016 Next Meeting Date:
Wednesday, October 19, 2016
2017
Meeting Dates:
Monday, January 16, 2017
Thursday, April 13, 2017
Tuesday, July 18, 2017
Thursday, October 12, 2017
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P&T Operational PolicyReview and vote
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Register to present at least 30 days prior to P&T
Information presented is restricted to randomized double blinded active control studies and published
or
accepted for publication in peer reviewed journal(s)
Limited to 3 minutes per drug per class and 1 representative per drug.
Not accepted:
Online publications
Poster presentations
Placebo-controlled, observational, open-label and non-randomized studies
Anecdotal reports
P&T Operational Policy: Pharma Testimony
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P&T Operational Policy: In-Person Public Comment ProtocolRegister to present at least 14 days prior to
P&T meeting.
First-come, first serve and limited to 15
total in-person public testimonies.
Presenters may not be employed by, speak on behalf of or represent a pharmaceutical manufacturer.
Limited to 3 minutes per
drug.
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Magellan Class Reviews
Classes
Antipsychotics (Atypical, long-acting injectables)
Stimulants and Related Agents
Anticoagulants
Pancreatic Enzymes
New Products (to Magellan PDL classes)
Taltz (Cytokine and CAM Antagonists)
Epclusa (Hepatitis C Agents)
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Antipsychotics
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Antipsychotics
Oral Agents
Abilify (aripiprazole)
Saphris (asenapine)
Rexulti (brexpiprazole)
Vraylar (cariprazine)
Clozaril (cariprazine)
Fazaclo (clozapine)
Versacloz (clozapine)
Seroquel (quetiapine)
Seroquel XR (quetiapine XR)
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Risperdal (risperidone)
Geodon (ziprasidone)
Fanapt (iloperidone)
Latuda (lurasidone)
Zyprexa (olanzapine)
Symbyax (olanzapine/fluoxetine)
Invega (paliperidone ER)
Nuplazid (pimavanserin)Slide10
Antipsychotics
Injectable Agents (Long-Acting)
Abilify Maintena (aripiprazole ER), monthly
Aristada (aripiprazole lauroxil ER), monthly or 6 weeks
Risperdal Consta (risperidone microspheres), 2 weeks
Zyprexa Relprevv (olanzapine), 2-4 weeks
Invega Sustenna (paliperidone palmitate), monthly
Invega Trinza (paliperidone palmitate), 3 months
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Antipsychotics
Class Overview - Product indications include*:
Schizophrenia, Bipolar disorder, major depressive order, schizoaffective disorder, irritability associated with autism, Tourette’s disorder, Parkinson's disease psychosis
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*Not inclusive of all product indications, all products differ in indicationSlide12
Antipsychotics
New Product in Class: Vraylar (cariprazine)
Treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder
Black box warning for increased mortality in elderly patients with dementia-related psychosis
Warnings include neuroleptic malignant syndrome, tardive dyskinesia, late-occurring adverse reactions (due to long half-life), metabolic changes, and orthostatic hypotension
Dose should be halved when given concurrently with strong CYP3A4 inhibitors – use with CYP3A4 inducers is not recommended
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Antipsychotics
New Product in Class: Vraylar (cariprazine) continued
Extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness are the most common adverse effects
Has not been adequately studied in pregnant women
Given once daily, available in 1.5, 3, 4.5, and 6 mg capsules
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Antipsychotics
New Product in Class: Nuplazid (pimavanserin)
Treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
Black box warning for increased mortality in elderly patients with dementia-related psychosis
Warnings include QT interval prolongation
Dose should be decreased by one half when given concurrently with strong CYP3A4 inhibitors; may need to be increased when given with strong CYP3A4 inducers
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Antipsychotics
New Product in Class: Nuplazid (pimavanserin) continued
Peripheral edema and confused state are the most common adverse effects
There are no data with Nuplazid in pregnant women to inform a drug-associated risk
Given once daily, available in 17 mg tablets
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Antipsychotics
Product/Guideline Updates:
Invega ,Orap and Abilify Discmelt are now available as a generics (September/October 2015)
The American Psychiatric Association practice guidelines on the use of antipsychotics to treat agitation or psychosis in patients with dementia does not provide specific drug recommendations, but mentions risperidone and aripiprazole as effective. Risperidone and olanzapine are addressed as having potential drawbacks in terms of adverse effects. (May 2016)
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Antipsychotics
Product/Guideline Updates:
The FDA reported that DRESS (drug reaction with eosinophilia and systemic symptoms) will be added to olanzapine labeling (all formulations) as a warning. (May 2016)
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Stimulants and Related Agents
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Stimulants and Related Agents
Class Overview:
Immediate Release Products
Amphetamine sulfate (Evekeo)
Dexmethylphenidate IR (Focalin)
Dextroamphetamine IR (Zenzedi)
Dextroamphetamine solution (ProCentra)
Methamphetamine (Desoxyn)Methylphenidate IR (Methylin, Ritalin)
Mixed amphetamine salts IR (Adderall)
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Stimulants and Related Agents
Class Overview: Extended Release Products
Amphetamine ER (Adzenys XR-ODT, Dyanavel XR)
Dexmethylphenidate ER (Focalin XR)
Dextroamphetamine ER (Dexedrine)
Lisdexamfetamine dimesylate (Vyvanse)
Methylphenidate ER OROS (Concerta)
Methylphenidate SR (Metadate ER)
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Stimulants and Related Agents
Class Overview:
Extended Release Products continued
Methylphenidate ER (Metadate CD, Quillichew ER, Quillivant XR, Ritalin LA, Aptensio XR)
Methylphenidate transdermal (Daytrana)
Mixed amphetamine salts ER (Adderall XR)
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Stimulants and Related Agents
Class Overview:
Non stimulants
Atomoxetine (Strattera)
Clonidine ER (Kapvay)
Guanfacine ER (Intuniv)
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Stimulants and Related Agents
Class Overview:
Product Indications
ADHD (attention deficit hyperactivity disorder), narcolepsy
Other: exogenous obesity, binge eating disorder
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Stimulants and Related Agents
New Product in Class: Aptensio XR (methylphenidate)
Treatment ADHD in patients six years and older
Contraindications, warnings, adverse effects, and drug interactions are similar to those for other controlled-release methylphenidate capsules
Given once daily in the morning and comes in 10, 15, 20, 30, 40, 50, and 60 mg extended-release capsules
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Stimulants and Related Agents
New Product in Class: Adzenys XR ODT (amphetamine)
Treatment of ADHD in patients six years and older
Contraindicated with coadministration of MAO inhibitors
Black box warning for high potential for abuse and dependence
Warnings include serious cardiovascular events, serious psychiatric events, long-term growth suppression, increased blood pressure and heart rate, and peripheral vasculopathy
Drug interactions include acidifying agents and alkalinizing agents, which can alter blood levels of amphetamine
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Stimulants and Related Agents
New Product in Class: Adzenys XR ODT (amphetamine)
Loss of appetite, dry mouth, abdominal pain, and insomnia are among reported adverse effects
It is in pregnancy category C
Given once daily in the morning
It is available as a extended-release orally disintegrating tablet in six different strengths (orange flavor)
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Anticoagulants
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Anticoagulants
Class Overview
Injectable Agents
Fragmin (dalteparin)
Lovenox (enoxaparin)
Arixtra (fondaparinux)
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Oral Agents
Eliquis (apixaban)
Pradaxa (dabigatran)
Savaysa (edoxaban)
Xarelto (rivaroxaban)
Coumadin (warfarin)Slide29
Anticoagulants
Class Overview - Product indications include*:
DVT and PE prophylaxis and treatment
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
Treatment of acute ST-segment elevation myocardial infarction managed medically or with subsequent percutaneous coronary intervention
To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
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*Not inclusive of all product indications, all products differ in indicationSlide30
Anticoagulants
Class Overview (Product indications include)*:
Prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement
Reduce the risk of death, recurrent myocardial infarction, and thromboembolic events, such as stroke or systemic embolization after myocardial infarction
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*Not inclusive of all product indications, all products differ in indicationSlide31
Anticoagulants
Product/Guideline Updates:
Praxbind, an intravenous reversal agent for Pradaxa, is now available (October 2015)
Pradaxa is now indicated for prophylaxis of DVT/PE in patients who have undergone hip replacement surgery, along with a new 110 mg strength for dosing convenience (December 2015)
Select portions of the American College of Chest Physicians guidelines were updated in 2016 to include Savaysa as a treatment option along with other oral anticoagulants (DVT/PE treatment) (March 2016)
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Pancreatic Enzymes
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Pancreatic Enzymes
Class Overview: Products
Zenpep
Creon
Viokace
Pancreaze
Pertzye
Ultresa
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Pancreatic Enzymes
Class Overview: Product Indications
Pancreaze, Pertzye, Ultresa, and Zenpep are indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions in both adults and children
Creon is indicated for these conditions, as well as exocrine pancreatic insufficiency due to chronic pancreatitis and pancreatectomy
Other conditions that may result in exocrine pancreatic insufficiency include ductal obstruction from a neoplasm and gastrointestinal bypass surgery
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Pancreatic Enzymes
Class Overview: Product Indications
Viokace is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in combination with a proton pump inhibitor in adults only
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New Products (to Magellan PDL classes)
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Taltz (ixekizumab)
Humanized IgG4 monoclonal antibody that inhibits the interleukin-17A (IL-17A) cytokine
Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Warnings include serious infections, tuberculosis, and exacerbations of inflammatory bowel diseases
Live vaccines should not be administered with Taltz
Injection site reactions, upper respiratory tract infections, nausea, and tinea infections are the most common adverse effects
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Taltz (ixekizumab)
There are no data in pregnant women to inform a drug-associated risk
Given as two 80 mg subcutaneous injections at weeks 0 followed by one 80 mg injection at weeks 2, 4, 6, 8, 10, and 12, then one 80 mg injection every four weeks
It is available as a 80 mg/mL solution for injection in a prefilled autoinjector or syringe
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Taltz (ixekizumab)
Three multicenter, randomized, double-blind, placebo-controlled trials - total of 3,866 adult patients with plaque psoriasis
Two studies included an active comparator arm in which subjects were also randomized to etanercept 50 mg twice weekly for 12 weeks
Trials evaluated the changes from baseline to Week 12 in 2 co-primary endpoints: 1) PASI 75 and 2)
sPGA
of “0” (clear) or “1” (minimal)
Patients treated with Taltz experienced greater improvement in both primary endpoints than etanercept, as well as statistically significant improvements in itch severity when compared to etanercept at week 12
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Taltz (ixekizumab)
Taltz is the second approved IL-17A inhibitor
Secukinumab (Cosentyx) is approved for plaque psoriasis as well as psoriatic arthritis and ankylosing spondylitis
Taltz joins a list of several other biologics indicated for the treatment of psoriasis
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Epclusa (sofosbuvir/velpatasvir)
Indicated for the treatment of chronic hepatitis C (all genotypes) in adults, with or without cirrhosis
Warnings include bradycardia with amiodarone co-administration
If given with ribavirin, contraindications and warnings for that drug also apply
Drug interactions occur with P-gp inducers and moderate-to-potent CYP inducers; use of Epclusa with these products is not recommended
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Epclusa (sofosbuvir/velpatasvir)
Fatigue and headache are the most common adverse effects
There are no data available in pregnant women to inform a drug-associated risk
Epclusa is given once daily for 12 weeks in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) and 12 weeks with ribavirin in patients with decompensated cirrhosis (Child-Pugh B, C)
It is available as sofosbuvir 400 mg and velpatasvir 100 mg combination tablets
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Epclusa (sofosbuvir/velpatasvir)
The efficacy and safety of Epclusa in patients with chronic HCV infection were evaluated in 4 randomized, multicenter, phase 3 trials: the ASTRAL trials
Primary outcome of sustained virologic response at 12 weeks after the end of treatment (SVR12)
Epclusa and resulted in treatment success rates of over 95% in all trials
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AASLD/IDSA Guideline Recommendations*
Genotype 1a and 1b
Zepatier for 12 weeks (compensated cirrhosis)
Harvoni for 12 weeks (compensated cirrhosis)
Harvoni + ribavirin for 12 weeks (decompensated cirrhosis)
Epclusa for 12 weeks (compensated cirrhosis)
Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)
Daklinza + Sovaldi for 12 weeks
Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis)
Viekira + ribavirin for 12 weeks
(1a)
Viekira for 12 weeks (compensated cirrhosis)
(1b)
Sovaldi + Olysio for 12 weeks
*Treatment Naïve (not including alternative therapies), July 2016
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AASLD/IDSA Guideline Recommendations*
Genotype 2
Epclusa for 12 weeks (compensated cirrhosis)
Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)
Daklinza + Sovaldi + ribavirin for 12 weeks for decompensated cirrhosis
Genotype 3
Epclusa for 12 weeks (compensated cirrhosis)
Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)
Daklinza + Sovaldi for 12 weeks (for 24 weeks with or without ribavirin for compensated cirrhosis)
Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis)
*Treatment Naïve (not including alternative therapies), July 2016
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AASLD/IDSA Guideline Recommendations*
Genotype 4
Zepatier for 12 weeks (compensated cirrhosis)
Harvoni for 12 weeks (compensated cirrhosis)
Harvoni + ribavirin for 12 weeks (decompensated cirrhosis)
Epclusa for 12 weeks (compensated cirrhosis)
Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)
Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis)
Technivie + ribavirin for 12 weeks (compensated cirrhosis)
*Treatment Naïve (not including alternative therapies), July 2016
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AASLD/IDSA Guideline Recommendations*
Genotype 5/6 (with or without cirrhosis)
Harvoni for 12 weeks
Epclusa for 12 weeks
*Treatment Naïve (not including alternative therapies), July 2016
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BH Drug ListSara Salek
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New Drug Reviews Sarah Martinez, PharmD Provider Synergies
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NEW DRUG REVIEWS
Cabometyx
-
Cabozantinib
Descovy
–
Emtricitabine &Tenofovir
Alafenamide Fumarate
Odefsey
- Emtricitabine, Rilpivirine, & Tenofovir Alafenamide Fumarate
Veltassa
- Patiromer Sorbitex Calcium
Venclexta
-
Venetoclax
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NEW DRUGS REVIEWS continued
The following will not be reviewed:
Cinqair
- Reslizumab
Onzetra Xsail & Zembrance Symtouch (formulations of Sumatriptan)
Sernivo - Betamethasone Dipropionate
Spritam – Levetiracetam
Ultravate Lotion – Halobetasol
Xtampza ER - Oxycodone
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Cabometyx - Cabozantinib S-Malate
Is a Kinase Inhibitor indicated for advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.
Dosage – 60mg daily 2 hours prior to or 1 hours after a meal.
No Black Box Warnings
Clinical Trials: Cabometyx was compared to Everolimus in a large muti-center study.
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Cabometyx - Cabozantinib S-Malate
The main outcome measure was progression free survival(PFS).
The PFS for the Cabometyx study arm was approximately twice as long as Everolimus: 7.4 months to 3.8months.
Adverse Reactions occurring in
>
20% of trial participants:
Most are expected with oncology medication, some of the unusual reactions were:
Hair color changes/depigmentation
Oral pain, Dysphonia
Hemorrhoids
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Cabometyx - Cabozantinib S-Malate
Recommendation is to add Cabometyx to the AHCCCS Drug List with prior authorization.
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Descovy - Emtricitabine (FTC) & Tenofovir Alafenamide (TAF)
Indicated for HIV-1 infection in combination with other antiretroviral agents.
Prodrug of Tenofovir Disoproxil Fumarate
Dosage: 1 tablet daily
Black Box Warning:
Lactic Acidosis/Severe Hepatomegaly
HIV-1 and Hepatitis B Coinfection
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Descovy - Emtricitabine (FTC) & Tenofovir Alafenamide (TAF)
Clinical Trials:
Treatment
na
ï
ve
and those on a stable antiretroviral regimen.
FTC
/TAF
w/
Elvitegravir
(EVG)/Cobicistat (COBI)
2 NRTIs + an Integrase Inhibitor + a Booster
92%
Treatment
na
ï
ve
and 96% of replacement regimens had HIV-1 RNA less than 50 copies per ml (48wk)
TAF being promoted as less side effects than Tenofovir Disoproxil.
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Descovy - Emtricitabine (FTC) & Tenofovir Alafenamide (TAF)
Adverse reactions occurring in
>
10% of the trial participants was nausea.
Recommendation is to add Descovy to the AHCCCS Drug List with prior authorization.
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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide
Indicated for HIV
-
1 treatment
infection
in
patients 12 years
of age and older as initial therapy in those with no antiretroviral treatment
history or
to replace a stable antiretroviral regimen in those who are
virologically suppressed
for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual
component.
Dosage: 1 tablet daily
Black Box Warning
Lactic Acidosis/Severe Hepatomegaly
HIV-1 and Hepatitis B
Co-infection
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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide
Clinical Trials
No head to head studies – FDA approval based on bioequivalence studies comparing the pharmacokinetics of Odefsey.
Studies included treatment na
ï
ve and treatment experienced patients
Odefsey contains Tenofovir Alafenamide,
a novel prodrug of tenofovir, which has a short half-live and limited bioavailability in the gastrointestinal
tract.
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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide
The
dose of
Tenofovir Alafenamide (TAF)
is approximately one-tenth of the dose of
Tenofovir Disoproxil Fumarate.
Due to the lower circulating plasma tenofovir levels with TAF,
the drug is being promoted as having lower
off-target side
effects.
Adverse reactions
occurring
in
>
10% of the trial participants were headache, depressive disorders &
insomnia.
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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide
Recommendation
is to
add Odefsey to
the AHCCCS Drug List
with prior authorization.
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Veltassa – Patiromer Sorbitex Calcium
Is a non-absorbed potassium binder and indicated to treat hyperkalemia.
Dosage: 1 packet daily
Black Box Warning: Veltassa binds to several oral medications which may affect the effectiveness of the oral agent. Oral medications should be taken 6 hours before or after Veltassa administration.
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Veltassa – Patiromer Sorbitex Calcium
Clinical Trials – Multinational, single-blinded, initial and withdrawal phases.
Results:
Initial phase
:
At the end of week 4, 76%
of patients (N=151)
reached
targeted
serum K+ of 3.8 to <5.1 mmol/L
.
Withdrawal phase:
At
the end of phase
1, participants
were randomly assigned to continue
Veltassa
(n=55) or
switched
to
placebo (N=51)
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Veltassa – Patiromer Sorbitex Calcium
Results continued
Recurrent
hyperkalemia (serum K+ ≥5.1 mmol/L) occurred in 91% of patients in the placebo group versus 43% in the Veltassa group.
Recurrent hyperkalemia (serum K+ ≥5.5 mmol/L) occurred in 60% of patients in the placebo group versus 15% in
the
Veltassa group.
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Veltassa – Patiromer Sorbitex Calcium
Adverse reactions
occurring
in
>
5% of the trial
participants
were hypokalemia, hypomagnesemia, constipation and diarrhea.
Recommendation is to add Veltassa to the AHCCCS Drug List
with prior authorization.
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Venclexta - Venetoclax
Is considered a breakthrough therapy and is indicated
for the treatment of chronic lymphocytic leukemia (CLL) in patients with 17p deletion as detected by an approved test in patients who have received at least
prior
therapy.
This indication is approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of the clinical benefit in a confirmatory trial.
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Venclexta - Venetoclax
Dosage is on
a
titration schedule beginning with 20mg and increasing
until
disease progression of unacceptable toxicity.
Black Box Warnings: None
Clinical Trials: Results of a Phase 2 single arm study with the primary endpoint of Overall Response Rate (OR)
Secondary endpoints of duration of response, progression free survival (PFS) and overall survival (OS) rates.
The estimated PFS and OS at 12 months were 72% and 86% respectively.
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Venclexta - Venetoclax
Adverse reactions occurring in >20% of the trial participants:
Fatigue, hyperkalemia, nausea.
h
yperphosphatemia,
c
onstipation, diarrhea, anemia, neutropenia, thrombocytopenia, and upper respiratory infection.
Recommendation is to add Venclexta to the AHCCCS Drug List with prior authorization.
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